The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Ecg Monitoring/defibrillation Electrode.
| Device ID | K854433 |
| 510k Number | K854433 |
| Device Name: | ECG MONITORING/DEFIBRILLATION ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Contact | Edward Shaughnessy |
| Correspondent | Edward Shaughnessy ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1986-05-08 |